510(k) Report

Devices descending from K042873

31 later devices reach Animas Model IR1250 Insulin Infusion Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080639Symphony Glucose Management SystemAnimas Corp.200827
+1K071613Amigo Insulin PumpNipro Diabetes Systems, Inc.200710—
+1K061110Glucommander PlusCollaborativemed, LLC200616—
+2K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc.20119Class I
+2K101344G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.)201013—
+2K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090—
+2K082590Symphony Meter RemoteLifescan, Inc.20080—
+2K071713Clarian Glucose Stabilizer Insulin Dosing CalculatorMedical Decisions Network20072—
+3K141758T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc.20147—
+3K141321Glucostabilizer Insulin Dosing CalculatorMedical Decision Network20140—
+3K133593T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc.20148—
+3K113853G+ SystemGlytec, LLC201212—
+3K081388Glucocare Intensive Glycemic Control SystemPronia Medical System, LLC20080—
+4K152300GlucommanderGlytec, LLC20171—
+4K160673Insulin Algorithms SystemInsulin Algorithms20170—
+4K160056t:slim Insulin Delivery SystemTandem Diabetes Care, Inc.20164—
+4K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20161—
+4K142918EndoTool SubQMonarch Medical Technologies20152—
+4K143189t:flex Insulin Delivery SystemTandem Diabetes Care, Inc.20152—
+4K132547Endo Tool Glucose Management System (Egms)Monarch Medical Technologies201481
+5K254102GlucommanderGlytec, LLC20260—
+5K240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.20242—
+5K200443EndoTool IV 1.10Monarch Medical Technologies, LLC20203—
+5K180366EndoTool SubQAl Pacheco and Associates20181—
+5K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20160—
+6K253534Pivot Insulin Delivery SystemModular Medical20261—
+6K211160EndoTool SubQ 2.1Monarch Medical Technologies, LLC20210—
+6K201619EndoTool IV SystemMonarch Medical Technologies, LLC20202—
+7K262153Pivot Insulin Delivery SystemModular Medical, Inc.20260—
+7K241088EndoTool IV (3.1)Monarch Medical Technologies20241—
+8K260910EndoTool IV Cloud 1.0Glooko, Inc.20260—